Friday, September 13, 2013

Don't Slack on Your Serial Number Manager

In the early days of enterprise pharma serialization solutions the Serial Number Manager (SNM) component was somewhat of an after-thought.    SNMs were typically looked upon to provide ranges of sequential numbers with an ability to report which ranges were allocated to which locations.  The prevalence of GS1 standards pushed SNMs to have native support for GS1 SGTINs and SSCCs but little flexibility beyond that.  

As long as SNM didn't allocate duplicate numbers everybody was happy. 

As I've stated in the past the big issue I see with most pharma serialization solutions is they are so specific to GS1 and so specific to E-Pedigree.  As serialization implementations heat up, whether it be for the US or abroad, the industry may be in for a rude awakening.

International regulatory requirements for randomization (EU), non-GS1 support (China), and support of serialization pre- SNM have introduced use cases for Serial Number Managers that many solution providers are struggling to keep up with.

A few key requirements that I consider to be must-haves in any SNM:

  • Must offer a non-pattern based Randomization option- Seems obvious but some leading providers don't utilize true randomization.
  • Complete control over the length and composition of Serial Numbers - Again seems like an obvious ones but too often pharma's are settling for solutions that limit the ability to generate SNs of specific lengths or using specific character sets.
  • Ability to assign SN configuration at a product level (i.e GTIN in the GS1 world)- Global pharma manufacturers need to assign different SN compositions at a product level to deal with regulatory differences across markets.   SNMs must also provide simple mechanisms to account for SNs that were allocated prior to SNM implementation, again at a product by product level.
  • Support for Non- GS1 keys- Understand that an SGTIN and SSCC are just two types of Unique Identifiers (UIDs) that exist in this world.   SNMs must be rooted in the ability to generate UIDs of any format or structure so that when something other than SGTIN or SSCC is needed it’s a matter of simple configuration. 

Contact me to review if your Serial Number Manager passes the test.

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